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Clinical Trials/NCT00225446
NCT00225446
Suspended
Phase 1

Computer-Assisted Orthognathic Surgery With a Third Generation Optic Repositioning System.

University Hospital, Grenoble1 site in 1 country20 target enrollmentFebruary 2006

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Computer-Assisted Surgery
Sponsor
University Hospital, Grenoble
Enrollment
20
Locations
1
Primary Endpoint
spatial coordinates of the target (3 translations and 3 rotations)
Status
Suspended
Last Updated
17 years ago

Overview

Brief Summary

The main objective of this study is to validate a simplified platform of a repositioning system in orthognathic surgery (a third generation optic repositioning system called MicronTracker) compared with the actual clinically validated one (Orthopilot system).

Detailed Description

For the past 10 years, the use of computer-assisted surgery has expanded and is now widely spread in the orthopaedic domain, but not in maxillary-facial surgery. The main disadvantages of this technique are the necessity to fix a mark on the eyebrow with two transcutaneous pins, which is a long and invasive act, and to connect the infrared transmitter which is in contact with the patient with the computer in a limited surgery area. In this study, we want to show that the new repositioning optic systems are performing similarly to the actual validated one, that they permit to suppress the transcutaneous pins and the computer connection, and that it reduces the financial cost of this surgery. Neither the surgery technique, nor the pre-operative check-up will be modified in the study. The two repositioning systems will be used simultaneously during the mandibular osteotomy.

Registry
clinicaltrials.gov
Start Date
February 2006
End Date
January 2009
Last Updated
17 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
University Hospital, Grenoble

Eligibility Criteria

Inclusion Criteria

  • Mandibular orthognathic surgery

Exclusion Criteria

  • Age \<18 years

Outcomes

Primary Outcomes

spatial coordinates of the target (3 translations and 3 rotations)

Time Frame: during surgery

Secondary Outcomes

  • time to install the eyebrow mark with each technique.(during surgery)
  • adverse events due to the transcutaneous pins.(during surgery)
  • number of handling realized by the nurse for each technique.(during surgery)
  • evaluation of cost: number of cable versus number of marker.(during surgery)

Study Sites (1)

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